Safety and Efficacy Study of Ceftolozane/Tazobactam to Treat Ventilated Nosocomial Pneumonia (MK-7625A-008)

Key Inclusion Criteria:

• Adult participants diagnosed with either VABP or ventilated HABP requiring IVantibiotic therapy;

• Intubated and on mechanical ventilation at the time of randomization;

• New or progressive infiltrate on chest radiography consistent with pneumonia;

• Presence of clinical criteria consistent with a diagnosis of ventilated nosocomialpneumonia.

Key Exclusion Criteria:

• History of moderate or severe hypersensitivity reactions to beta-lactam antibiotics;

• Prior non-study antibiotics for > 24 hours;

• Gram stain of lower respiratory tract specimen showing only gram positive bacteria;

• Active immunosuppression;

• End-stage renal disease or requirement for dialysis;

• Expected survival < 72 hours;

• Severe confounding respiratory condition (i.e., chest trauma with paradoxicalrespiration);

• Known or suspected community-acquired bacterial pneumonia.

• Anticipated concomitant use of any of the following medications during the course ofstudy therapy: valproic acid or divalproex sodium. Anticipated concomitant use ofserotonin re-uptake inhibitors, tricyclic antidepressants, or serotonin 5-HT1 receptoragonists (triptans), meperidine, or buspirone during the course of linezolidtreatment.

• Receipt of a monoamine oxidase inhibitor within 14 days prior to the first dose ofstudy drug or anticipated concomitant use during the course of linezolid therapy.